Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging sys...
FDA Device Recall #Z-0514-2018 — Class II — December 15, 2017
Recall Summary
| Recall Number | Z-0514-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 15, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Philips Medical Systems (Cleveland) Inc |
| Location | Cleveland, OH |
| Product Type | Devices |
| Quantity | 1387 in total |
Product Description
Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Precedence may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Precedence may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Precedence Imaging System should only be used by trained healthcare professionals.
Reason for Recall
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Distribution Pattern
Worldwide Distribution - US Nationwide
Lot / Code Information
Precedence 6 Model # 882351 Serial Numbers : KP05100002 KP06040012 KP05040006 KP05080007 KP05110003 KP0510008 30008 KP06110019 K06110017 6080522 30007060027 3000034 3000032 30007060029 3000006 KP06020011 KP06050013 KP06080008 KP05110004 KP06110018 30007040026 KP06070015 30007060028 3000033 30007030025 3000031 3000035 3000040 3000041 30058 3000049 3000054 3000039 3000038 3000042 3000093 3000044 3000036 3000043 3000047 KP06070048 3000074 3000059 3000055 340090 3000057 3000058 3000053 3000050 3000056 3000052 3000061 3000051 3000045 3000048 3000069 3000066 3000078 3000060 3000064 3000068 3000065 30007070030 3000071 3000063 3000067 3000062 300072 3000095 3000073 3000085 30007080011 30007040024 3000102 3000075 3000076 7021 3000092 3000098 3000087 3000077 3000082 3000080 3000081 3000088 3000079 3000083 3000084 3000089 3000091 3000096 3000097 3000100 3000086 3000090 3000099 3000094 3000104 3000101 3000103 3000105 3000106 3000037 3000708005 30006120020 30007020023
Other Recalls from Philips Medical Systems (Cleveland) Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2570-2025 | Class II | Pinnacle Radiation Therapy Planning System: ... | Aug 5, 2025 |
| Z-2239-2025 | Class II | Pinnacle 3 with TumorLOC, (870258) Radiation Th... | Jul 17, 2025 |
| Z-1744-2022 | Class II | Pinnacle3 Radiation Therapy Planning System, Mo... | Aug 30, 2022 |
| Z-0213-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
| Z-0217-2020 | Class I | Forte Gamma Camera System is intended to produc... | Sep 19, 2019 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.